Smiley Gripper

Dosage form: paste
Ingredients: SODIUM FLUORIDE 0.243g in 100g
Labeler: Dr. Fresh, Inc.
NDC Code: 64893-495

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Smiley Gripper

Active Ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Uses

Helps prevent cavities

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately

Keep out of the reach of children under 6 years of age.

Directions

Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day  as directed by a dentist or physician. Do not swallow

To minimize swallowing use a pea-sized amount in children under 6.

Supervise children's brushing until good habits are established.

Children under 2 years: Ask a dentist

Inactive Ingredients

Sorbitol, water, hydrated silica, trisodium phosphate, sodium lauryl sulfate, flavor, sodium phosphate, xanthan gum, carbomer 956, sodium saccharin, titanium dioxide, blue no. 1

Comments? Questions?

Dr. Fresh Inc

Buena Park, CA 90620 USA

Toll Free: 1-866-DR-FRESH

Visit us at: www.drfresh.com

Smiley Gripper
Crest has been shown to be an effective decay-preventative dentifrice that can be of significant value when used as directed in a conscientiously applied program of oral hygiene and regular professional care.
Council on Scientific Affairs - American Dental Association

This product contains no sugar, like all ADA Accepted toothpastes.

The Smiley Gripper toothbrush is specially designed to stick and stand on bathroom counters and sink to avoid contamination.

CAUTION/CHOKING HAZARD:
This product is not a toy and should always be used with adult supervision. Not intended for children under 3 years of age. Do not let kids chew or pull apart rubber end.

Crest(R) toothpaste is a product of Procter and Gamble, Cincinnati, OH USA

Distributed by
Dr. Fresh, Inc.
Buena Park, CA 90620 USA

Canada- Dr. Fresh Inc. Ontario Canada L7C2T4
268 Bath Road, Slough, Berkshire SL1 4DX

Questions? Comments? Toll Free:
1-866-373-7374  USA 1-714-690-1573

UK and IRL: +44(0)1753 725365
comments@drfresh.com
visit us online at
www.drfresh.com   www.drfresh.co.uk

Toothpaste and packaging Made in U.S.A.,
Toothbrush made in PRC

Smileguard and related trademarks, names, logos and patents are the property of Dr. Fresh, Inc. and are registered and/or used in the U.S. and countries around the world (c) 2011 Dr. Fresh, Inc. Patent Pending

SMILEY GRIPPER 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-495
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.243 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
HYDRATED SILICA 
PHOSPHATE ION 
SODIUM LAURYL SULFATE 
SODIUM PHOSPHATE 
XANTHAN GUM 
SACCHARIN SODIUM 
MICA 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:64893-495-011 TUBE (TUBE) in 1 PACKAGE
124 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/20/2011
Labeler - Dr. Fresh, Inc. (033059119)

Revised: 06/2011
 
Dr. Fresh, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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